@article{3077398, title = "Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study", author = "Bahlis, N.J. and Dimopoulos, M.A. and White, D.J. and Benboubker, L. and Cook, G. and Leiba, M. and Ho, P.J. and Kim, K. and Takezako, N. and Moreau, P. and Kaufman, J.L. and Krevvata, M. and Chiu, C. and Qin, X. and Okonkwo, L. and Trivedi, S. and Ukropec, J. and Qi, M. and San-Miguel, J.", journal = "Leukemia Research", year = "2020", volume = "34", number = "7", pages = "1875-1884", publisher = "Springer Nature BV", issn = "0145-2126", doi = "10.1038/s41375-020-0711-6", keywords = "daratumumab; dexamethasone; lenalidomide; antineoplastic agent; daratumumab; dexamethasone; lenalidomide; monoclonal antibody; thalidomide, adult; aged; anemia; Article; cataract; controlled study; diarrhea; drug efficacy; drug response; drug safety; fatigue; febrile neutropenia; female; follow up; high throughput sequencing; human; hypokalemia; intention to treat analysis; lung embolism; lymphocytopenia; major clinical study; male; minimal residual disease; multiple cycle treatment; multiple myeloma; neutropenia; phase 3 clinical trial; pneumonia; priority journal; progression free survival; randomized controlled trial; septic shock; thrombocytopenia; treatment duration; clinical trial; drug effect; drug resistance; multicenter study; multiple myeloma; pathology; prognosis; salvage therapy; survival rate; tumor recurrence, Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Female; Follow-Up Studies; Humans; Lenalidomide; Male; Multiple Myeloma; Neoplasm Recurrence, Local; Prognosis; Salvage Therapy; Survival Rate; Thalidomide", abstract = "In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1–21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35–0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10–5; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31–0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42–0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse. © 2020, The Author(s)." }